Use cautionMedical device recall · FDA · Published November 12, 2021
Philips BV Endura X-ray System Recall: Risk of Burns from Unspecified Tank Temperature
Philips recalls mobile X-ray systems with software release 2.3 due to instructions not specifying maximum surface temperature of X-ray tank, which can cause burns.
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
Take action
Contact the company
📍Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289
✎ GovInfoNow plain-language explainer
Philips is recalling mobile X-ray imaging systems with software version 2.3 because the instructions don't state the maximum safe temperature for the X-ray tank. This could lead to burns if the tank overheats. Affected units have specific model and serial numbers listed in the recall notice. Read more at govinfonow.com/recall/61537-philips-bv-endura-x-ray-system-recall-risk-of-burns.
“Philips BV Endura X-ray System Recall: Risk of Burns from Unspecified Tank Temperature.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61537-philips-bv-endura-x-ray-system-recall-risk-of-burns. Based on FDA recall #Z-0355-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0355-2022%22&limit=1).
The FDA announced on 2021-11-12 that Philips North America Llc is recalling BV Endura mobile diagnostic X-ray systems due to burn hazards. The agency said the recall addresses Instructions for Use that fail to specify maximum surface temperatures for key components.
How to tell if you have it
Brand: Philips
Product: BV Endura with Software Release 2.3
Model Number: 718075
UPC: 00884838055490
The hazard
The FDA said the Instructions for Use do not specify the maximum surface temperature of the X-ray tank and the image intensifier/detector as required. This omission can result in burns to users.
Context
GovInfoNow's records show Philips North America Llc has 129 other recalls on record since 2017-07-12. Recent recalls include the Ingenia 1.5T series (2026-08-21), the Spectral CT 7500 Scanner (2026-08-18), and the Brilliance CT 64 Medical Scanner (2026-08-07). Other recent recalls of similar products include the Philips Integris-Allura System Recall (2026-04-28) and the Philips Azurion System Recall (2026-04-28).
How to tell if you have this one
Check for model number 718075 and serial numbers starting with 173. The system was sold with software release 2.3 between 2020 and 2023. The unique device identifier (UDI) is listed in the recall notice.
Brand
Philips
Product
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Afghanistan, Algeria, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cameroon, Chile, China, Colombia, Cook Islands, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives Mali, Martinique, Mauritius, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia, Zimbabwe.
Identify your model number (718075) and serial number to confirm if your unit is affected.
Stop Using Immediately
If you have the affected software version, stop using the system until you can contact Philips for further instructions.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Afghanistan, Algeria, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cameroon, Chile, China,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0355-2022 (November 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0355-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.